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Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Ac…
EUDAMEDClass C (EU MDR)
Ref BSJ02L1Model BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1ARef BSJ02S1
Identity
- Trade Name
- Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR) EUDAMED
- Device Name
- Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit EUDAMED
- Model / Reference
- BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A EUDAMEDBSJ02L1 EUDAMEDBSJ02S1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06973843227771 EUDAMED06973843227856 EUDAMED
- Basic UDI-DI
- 697384322BSJ02JC EUDAMED
- Direct Marketing DI
- 06973843227771 EUDAMED06973843227856 EUDAMED
- EMDN Code
- W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Ac… by Hangzhou Bioer Technology Co., Ltd. — Class C — IVDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 697384322BSJ02JC | Class C | Active |
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Manufacturer
- Manufacturer
- Hangzhou Bioer Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000019512
- Authorised Representative
- MedNet EC-REP GmbH DE-AR-000000002
Sources (2)
- EUDAMED 161a88d3-74fe-413b-adf2-0ee46a112a76 61 fields · synced Jul 12, 2026
- EUDAMED 947dabbb-21bb-446e-9123-11d0573597f0 61 fields · synced May 18, 2026